Study Indication and Rationale, Theory of Mechanism of Operation, & Supporting Materials


The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.


 

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End of Study Activities

End of study for a subject is determined as either completion of the final study visit at the end of the post-procedure phase as per protocol, or completion of an earlier visit due to a subject’s early voluntary withdrawal or early investigator termination.

END OF STUDY FORM
The END OF STUDY case report form will be completed at the time of the subject’s final study visit. The END OF STUDY form will document if the subject completed the entire study as per protocol, or the date and reason for early termination.

EARLY STUDY TERMINATION FORM
The EARLY STUDY TERMINATION case report form will be completed if the subject’s final study visit is the not the study final visit. The EARLY STUDY TERMINATION form will document the date of early termination, the last study visit/action completed, whether the early termination was initiated by the subject or the Principal Investigator, and the reason for the early termination.

  • Exit Physical Examination, as per the study qualification evaluation.
  • Exit Neurological Examination, as per the study qualification evaluation.

The Schedule of Study Activities that outlines all of the subject activities from study entry to completion is contained in Appendix E.




 
 

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.

 
 

Pico-Tesla Magnetic Therapies are holding clinical trials for Parkinson’s patients. They are testing to see if the new Resonator® device, using pulsed magnetic field therapy, is successful in improving the quality of life for people living with Parkinson’s disease. Those who qualify for these clinical trials will be compensated.

Currently, these clinical trials are being held in Novi, Michigan and Clearwater, Florida. All locations are in close proximity to major cities in each state. Patients interested in participating can contact Pico-Tesla for more information.